Ondansetron
- Product NDC
- 0641-6286
- 11-digit product format
- 006416286
- Labeler code
- 0641
- Product ID
- 0641-6286_4936a082-34d2-4cd3-9740-3a55ac939b2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA077365
- Marketing category
- ANDA
- Marketing start
- 2006-12-26
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| NMH84OZK2B | ONDANSETRON HYDROCHLORIDE | 103639-04-9 | ONDANSETRON HYDROCHLORIDE |
| 4AF302ESOS | ONDANSETRON | 99614-02-5 | Ondansetron |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6286-01 | 00641628601 | 20 mL in 1 VIAL, MULTI-DOSE (0641-6286-01) | 20 ml | 2006-12-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ondansetron | Hikma Pharmaceuticals USA Inc. | 2026-04-16 | HUMAN PRESCRIPTION DRUG LABEL | 20 |